title: [Safety and use of gadobutrol in patients with brain tumors (phase III trial)].
abstract: OBJECTIVE
  The purpose of the study was to investigate the use and safety of Gadobutrol, a new low-osmolar, non-ionic contrast agent for MRI using a total dose of 0.3 mmol/kg b.w. on the basis of a clinical phase 3 study.
  
  
  METHODS
  30 patients with primary brain tumours (n = 15) or cerebral metastases (n = 15) were examined via MRI before and after application of a total of 0.3 mmol/kg b.w. given in two fractions (0.1 and 0.2 mmol/kg b.w.). T2-weighted images were performed before, T1-weighted images before, between and after application of contrast material.
  
  
  RESULTS
  In this study one-molar Gadobutrol showed a good tolerance. In half of the cases the contrast between lesion and brain was improved comparing single and triple dose, but this means only a slightly improvement of information for the primary brain tumours compared with single dose. The detected metastatic lesions increased in 40% of the patients after the single dose and in 53% of the patients after cumulative triple dose. There was a consecutive change in therapy in 20% of the patients.
  
  
  CONCLUSIONS
  For the differentiation of primary brain tumours the single dose was sufficient, in metastatic lesions triple dose was essential for the detection or exclusion of multifocality.
authors.affiliation: Strahlenklinik und Poliklinik, Humboldt-Universität zu Berlin.
authors.forename: A J
authors.initials: AJ
authors.lastname: Lemke
authors.forename: B
authors.initials: B
authors.lastname: Sander
authors.forename: T
authors.initials: T
authors.lastname: Balzer
authors.forename: V
authors.initials: V
authors.lastname: Geens
authors.forename: N
authors.initials: N
authors.lastname: Hosten
authors.forename: R
authors.initials: R
authors.lastname: Felix
mesh_terms: D000236:Adenoma / Q000175:diagnosis; D000328:Adult; D000368:Aged; D001254:Astrocytoma / Q000175:diagnosis; D001932:Brain Neoplasms / Q000175:diagnosis* / Q000556:secondary; D003287:Contrast Media / Q000008:administration & dosage; D003397:Craniopharyngioma / Q000175:diagnosis; D005260:Female; D005682:Gadolinium / Q000008:administration & dosage; D018325:Hemangioblastoma / Q000175:diagnosis; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods*; D008297:Male; D008579:Meningioma / Q000175:diagnosis; D008875:Middle Aged; D009837:Oligodendroglioma / Q000175:diagnosis; D009942:Organometallic Compounds / Q000008:administration & dosage; D010911:Pituitary Neoplasms / Q000175:diagnosis; D012449:Safety
chemical_list: D003287:Contrast Media; D009942:Organometallic Compounds; C090600:gadobutrol; D005682:Gadolinium
vernacular_title: Sicherheit und Nutzen von Gadobutrol bei Patienten mit zerebralen Tumoren (Phase-III-Studie).